Technical Support

Latex Content

Effective September 28, 1998, the United States Food and Drug Administration requires all medical device manufacturers label products that contain dry natural rubber or natural rubber latex in the product’s Directions for Use. To the best of our knowledge unless otherwise described in this Web site, the product’s packaging and / or directions for use, Nellcor™, Puritan Bennett™, Mallinckrodt™ anesthesiology and Shiley™ tracheostomy products do not contain dry natural rubber or natural rubber latex.

If you have questions about the latex status of a particular product, please consult the product’s directions for use. If you cannot locate the product’s directions for use, please contact a local Covidien sales representative.

The following information will assist customers and distributors to quickly and accurately identify the Covidien respiratory and monitoring products contain latex.

**This product has latex components, which do not come in direct contact with the patient's skin. There is no known risk associated with this product due to the presence of latex.

Blood Pressure Cuff

Covidien Product

Catalog Number

Components Containing Latex

Infant reusable blood pressure cuff

SCBP-6R

Internal cuff bladders

Child / small adult reusable blood pressure cuff

SCBP-9R

Internal cuff bladders

Adult reusable blood pressure cuff

SCBP-12R

Internal cuff bladders

Large arm reusable blood pressure cuff

SCBP-15R

Internal cuff bladders

Thigh reusable blood pressure cuff

SCBP-18R

Internal cuff bladders

These cuff bladders are enclosed in a Dacron bag that includes a urethane lining barrier, however the hose that extends from the cuff may also contain latex. For blood pressure cuffs shipped after February 1, 1997, the blood pressure cuff hose has been treated to provide an external coating of neoprene over the exposed area to minimize the likelihood of latex containing parts making skin contact. The shipping date of the cuff can be determined by examining the date code on the Dacron flap of the blood pressure cuff. The Dacron flap is normally tucked inside the cuff at the hose insertion point. The Nellcor™ SHBP-10 hose, which interfaces between the monitor and blood pressure cuff, does not contain latex. At present, Covidien has not validated any other vendors' reusable cuffs. Latex free neonatal cuffs are available for use with the N-3100.

Oximetry Sensors

In the past, the adhesive coating of the bandage on the Nellcor™ SpO2 sensors (models I-20, I-20R, N-25 and N-25R), Nellcor™ Infant SpO2 Sensor (model I), Nellcor™ Neonatal-Adult SpO2 Sensor (model N) and Nellcor™ Adult-Neonatal Adhesive Sensor Wrap (model ADH-A/N), may have contained a minute amount of natural latex. This material is the same type used in commercial adhesive bandages. Please see below for current information on these products and other sensors.

In the past, latex-free Nellcor™ SpO2 sensors (models N-25LF and I-20LF) were made to meet customer needs. The letters LF indicated these products to be latex free. As of April 2001, the Nellcor™ SpO2 sensors (models I-20 and N-25) have been standardized and are now labeled as latex free. The letters LF have been removed from the product number to minimize redundancy. The initial lot number for latex free sensor (model I-20) is C29017 and the initial lot number for latex free sensor (model N-25) is C29018.

As of June 2002, the Nellcor™ SpO2 Sensors (models N and I) are latex free. As of January 2002, the Nellcor™ Adult-Neonatal Adhesive Sensor Wrap (model ADH-A/N) is latex free.

Early pouches of the disposable Nellcor™ SpO2 sensor line (models MAXA, MAXAL, MAXP, MAXI, MAXN and MAXR) did not state that the products were latex free; however these sensors have always been and will continue to be latex-free.

Private label NOVAPLUS pulse oximetry sensors (models VN-25 and VI-20) are identical in quality and material to the Nellcor™ SpO2 sensors (models N-25 and I-20). They are also latex free.

Shiley™ Tracheostomy Products

The Shiley tracheostomy tube and accessory products are composed of medical grade plastics that do not contain latex material. All packaging of Shiley tracheostomy products are free of latex.

Covidien Product

Catalog Number

Components Containing Latex

Shiley™ tracheostomy tube and accessory products

All catalog numbers

NONE

Ventilator and Respiratory Accessory Products

Covidien Product

Catalog Number

Components Containing Latex

Test lung

4-000612-00

Contains latex

SPU Filter

4-010793-00

Contains latex

Raindrop Nebulizer with Adult Mask

6-001045-00

Strap only

Raindrop Nebulizer with Pediatric Mask

6-001124-00

Strap only

Test Lung Assembly

N-4403019

Contains latex

The following Puritan Bennett™ ventilator systems do not contain latex:

Puritan Bennett™ 740 ventilator

Puritan Bennett™ 760 ventilator

Puritan Bennett™ 840 ventilator

Puritan Bennett™ 806 compressor

Puritan Bennett™ 7200 ventilator – does not contain latex components that would come in contact with patients or users

Miscellaneous Products – Latex Content Not Yet Determined

The latex content status of the parts listed in the following table has not yet been confirmed. Until the latex content status of these parts is resolved, Covidien suggests that they be assumed to contain latex.

Covidien Product

Catalog Number

Status

Breathing bag

F-503100-00

Inactive part

Breathing bag

F-503101-00

Inactive part

Breathing bag

F-503102-00

Inactive part

Breathing bag

F-503104-00

Breathing bag

F-503202-00

Inactive part

Form it mask

F-651100-00

Form it mask

F-651101-00

Form it mask

F-651103-00

Form it mask

F-651104-00

Form it mask

F-651105-00

Inactive part

Form it mask

F-651106-00

Packaging of Nellcor™ Critical Care Products

All packaging of Nellcor™ Critical Care Products are free of latex. The table immediately following this line is a quick reference guide to latex free products.